The placebo controlled study involving 60 healthy volunteers would test escalating doses of the vaccine in prime-boost regimen
Bharat Biotech announced that the phase I, first in human clinical trials of the indigenously developed Chikungunya (CHIKV) vaccine, is underway in India to evaluate the vaccine’s safety, tolerability and immunogenicity. The placebo-controlled study involving 60 healthy volunteers would test escalating doses of the vaccine in prime-boost regimen.
Bharat Biotech developed the CHIKV vaccine using an isolate of the virus from Indian epidemic. The inactivated virus vaccine developed by the in-house R&D was found to be safe and immunogenic in pre-clinical animal testing. After successful completion of product development and pre-clinical testing, the candidate vaccine was approved by the Drug Controller General (India) (DCG(I)) for phase I clinical trials in 2016.
According to Dr Krishna Ella, CMD, Bharat Biotech, “Chikungunya is one among the modern day most dreaded virus, and developing an efficient vaccine to prevent it means a lot to people at risk for the infection. Our pre-clinical studies were promising and we hope that the first–in –human clinical trials successfully meets with the clinical endpoints.”
The company informed, the candidate vaccine under development cross neutralised CHIKV isolates of the Asian genotype isolated in 1963 and isolates from the successive Indian epidemics caused by the East Central South African (ECSA) genotype since 2006. While CHIKV exists as three genotypes, there is only a single serotype of the virus. The candidate vaccine developed by Bharat Biotech effectively cross neutralised both the Asian and ECSA CHIKV genotypes.
Reportedly, Bharat Biotech filed a globally pioneering patent in 2007 for CHIKV drawing priority from 2006, and followed up with a second patent in 2011. Patents have been granted in the US, Europe, China, Indonesia, South Africa and is in National phase in several other countries. If phase I clinical testing is successful, Bharat Biotech plans to advance the vaccine into phase II/III clinical development.